Statistical Programmer II

🔥 29 minutes ago

🇹🇼 Taiwan – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🖥 Software Engineer

👻 Ghost score 10%

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Everest Clinical Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2004

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Everest Clinical Research is a global contract research organization (CRO) that provides end-to-end clinical trial services and biometrics expertise to pharmaceutical and biotechnology sponsors. The company offers clinical operations and project management, risk-based quality management and centralized monitoring, medical monitoring, pharmacovigilance, clinical data management, biostatistics and statistical programming, regulatory strategy and submissions, and technology solutions such as IRT/RTSM and ePRO/eCOA. Everest positions itself as a high-touch, quality-driven partner with global reach and therapeutic expertise across oncology, neurology, respiratory, rare diseases and immunology.

📋 Description

• Develop and review SDTM and ADaM dataset specifications, annotated CRFs, define.xml, reviewer’s guides, and related documents • Program and validate SDTM and ADaM datasets • Perform CDISC conformance checks and address findings • Develop SAS programs for statistical output reports based on SAP and TLG mock-up shells • Provide programming support for Clinical Study Reports, integrated safety and efficacy analyses, regulatory safety reports, ad-hoc requests, and exploratory analyses • Develop and maintain SAS programs for database integrity checks and ongoing data cleaning • Reconcile CRF and non-CRF data and perform non-CRF data integrity checks • Generate data listings, summary tables, graphs, and Patient Profiles • Document data and programming information according to SOPs and WIs • Achieve audit readiness and defined statistical programming performance indicators • Maintain knowledge of industry standards and regulatory requirements • Develop and provide expertise in other programming and system administration areas when required

🎯 Requirements

• Master’s or Ph.D. degree in statistics, biostatistics, epidemiology, public health, bioinformatics, mathematics, or computer sciences • SAS certified Base, Advanced, and Clinical Trials Programmers are highly preferred • Exposure/experience in clinical trial statistical programming and/or data analysis is desirable • Current knowledge of pharmaceutical clinical research industry standards, conventions, and regulatory requirements • Knowledge of clinical trial Sponsor-specific requirements when applicable • Compliance with Everest company-specific and clinical trial Sponsor-specific training requirements

🏖️ Benefits

• Equal opportunity and accommodations for candidates with disabilities • Remote or hybrid work options for the Taiwan location